MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45015
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that post-procedure, the patient suffered an ischemic stroke due to the subject stent was not opened on the proximal end.The physician was unable to re-access the subject flow diverter to open the proximal part.The patient's anatomy was reported to be moderately tortuous and had a short tight landing zone.The patient current condition was unknown and no further information was available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based on the information provided in the complaint, it is not clear if the subject flow diverter caused the patient stroke.Access was through the femoral artery.The associate device used in conjunction with the subject flow diverter during the procedure was a long sheath, an intermediate catheter and a microcatheter.The subject flow diverter was confirmed to be fully deployed during the procedure.The anatomy was not extremely tortuous.Regular imaging was done immediately post procedure to show that the flow diverter was fully open.The flow diverter did not fully oppose the vessel wall proximally when it was deployed, the ledge on the proximal end meant the flow diverter was not fully open and fish mouthing effort.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported issue of the stent failed/unable to open.An assignable cause of anticipated procedural complication will be assigned to the reported event of patient stroke as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that post-procedure, the patient suffered an ischemic stroke due to the subject stent was not opened on the proximal end.The physician was unable to re-access the subject flow diverter to open the proximal part.The patient's anatomy was reported to be moderately tortuous and had a short tight landing zone.The patient current condition was unknown and no further information was available.

• Brand Name: SURPASS EVOLVE 4.5MM X 15MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14994244
• Report Number: 3008881809-2022-00342
• Device Sequence Number: 1776818
• Product Code: OUT
• UDI-Device Identifier: 07613327375244
• UDI-Public: 07613327375244
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: FDS45015
• Device Catalogue Number: FDS45015
• Device Lot Number: 22810419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH (STRYKER); EXCELSIOR XT - 27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown